Ultrasonic probe device having an impedance mismatch with rapid attachment and detachment means

• US 20030036705A1
• Filed: 10/10/2002
• Published: 02/20/2003
• Est. Priority Date: 10/05/1999
• Status: Abandoned Application

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Robertson, Roy M., Varady, Mark J., Ranucci, Kevin J., Rabiner, Robert A., Hare, Bradley A., Marciante, Rebecca I.
• Application Number:
  US10/268,487
• Publication Number:
  US 20030036705A1
• Time in Patent Office: Days
• US Class Current: 600/437
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22007 Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ultrasonic tissue ablation device comprising a transversely vibrating small-diameter probe and a coupling assembly for probe attachment and detachment that that enables the probe to disengage from the device body. The probe detachability allows for insertion, manipulation, and withdrawal independently of the device body. The probe can be used with acoustic and/or aspirations sheaths to enhance tissue ablation. The device body includes an ultrasonic energy source and a horn assembly. The probe of the present invention is engaged to the device body in a manner which creates an impedance mismatch between the probe and the device body which allows the probe and the device body to operate as separate acoustic systems. The present invention also comprises a method for the removal of vascular occlusions in a blood vessels.

Claims

1. A device for treating occlusions in a body comprising:

a probe having a proximal end and a distal end;

a horn having a first connection end and a second connection end wherein the first connection end engages the proximal end of the probe;

a handle engaging the second connection end of the horn; and

a discontinuity at a point of attachment where the probe engages the horn wherein the discontinuity creates an impedance mismatch between the probe and the horn.

2. The device of claim 1 wherein a diameter of the probe is approximately 0.025 inches or less.

3. The device of claim 1 wherein a diameter of the probe varies from the proximal end to the distal end of the probe.

4. The device of claim 1 wherein the handle is capable of delivering ultrasonic energy from the handle to the probe.

5. The device of claim 1 wherein the probe oscillates in a transverse mode.

6. The device of claim 1 wherein the horn is a mason horn.

7. The device of claim 1 wherein a length of the horn approximates an integer multiple of one-half wavelength of a vibration.

8. The device of claim 1 wherein the horn is a longitudinal drive system.

9. The device of claim 1 wherein the horn is a transverse drive system.

10. The device of claim 1 wherein the discontinuity is placed at a location of an anti-node along the probe.

11. The device of claim 1 wherein the discontinuity is placed at a location of a node along the probe.

12. The device of claim 7 wherein the length of the horn is increased by approximately one-fourth of a wavelength when the discontinuity is placed at a location of a node along the probe.

13. The device of claim 12 wherein a second discontinuity is placed approximately one-fourth of a wavelength away from the discontinuity at the point of attachment of the probe and the horn.

14. The device of claim 1 wherein the discontinuity is created by a significant decrease in a diameter between the probe and the horn at the point of attachment.

15. The device of claim 1 wherein the discontinuity is created by a dense material comprising the horn and a less dense material comprising the probe.

16. The device of claim 1 wherein the horn is comprised of aluminum or an aluminum alloy.

17. The device of claim 1 wherein the horn is comprised of steel or a ferrous material.

18. The device of claim 1 wherein the probe is comprised of titanium or a titanium alloy.

19. The device of claim 1 wherein the discontinuity is created by using a horn comprised of a first material having a first elastic modulus and a probe comprised of a second material having a second elastic modulus wherein the first elastic modulus and the second elastic modulus are different.

20. The device of claim 1 wherein the discontinuity results in a return of approximately 80 percent of the ultrasonic energy generated in the handle back into the horn and a transfer of the remaining approximately 20 percent of the ultrasonic energy into the probe.

21. The device of claim 1 wherein the horn is independent of a vibrational motion of the probe.

22. A device for removing occlusions in a blood vessel comprising:

an ultrasonic probe comprising a proximal end and a distal end;

a sound conductor comprising a proximal end and a distal end, wherein the distal end of the sound conductor is engaged to a coupling assembly and the proximal end of the sound conductor is engaged to a transducer capable of providing ultrasonic energy; and

a discontinuity between the ultrasonic probe and the sound conductor at a point of attachment between the ultrasonic probe and the sound conductor,

wherein the ultrasonic probe is releasably mounted at the proximal end of the ultrasonic probe to the coupling assembly, enabling the sound conductor to transmit ultrasonic energy from the transducer to the ultrasonic probe, causing the ultrasonic probe to oscillate in a substantially transverse mode with respect to a longitudinal axis of the ultrasonic probe.

23. The device of claim 22 wherein the ultrasonic probe is a flexible, elongated wire.

24. The device of claim 22 wherein a diameter of the ultrasonic probe varies along the longitudinal axis of the ultrasonic probe.

25. The device of claim 22 wherein the flexural stiffness of the ultrasonic probe varies along the longitudinal axis of the ultrasonic probe.

26. The device of claim 22 wherein a diameter of the ultrasonic probe remains constant along the longitudinal axis of the ultrasonic probe.

27. The device of claim 22 wherein a length of the ultrasonic probe is between approximately 30 centimeters and approximately 300 centimeters.

28. The device of claim 22 wherein the ultrasonic probe further comprises a sheath assembly adapted to the ultrasonic probe that includes at least one sheath.

29. The device of claim 28 wherein the sheath assembly substantially prevents transmission of cavitational energy generated by the ultrasonic probe to a surrounding environment.

30. The device of claim 28 wherein the sheath assembly further comprises at least one fenestration in the at least one sheath.

31. The device of claim 30 wherein the fenestration in the at least one sheath is capable of transmitting cavitational energy therethrough to the surrounding environment.

32. The device of claim 28 wherein the sheath assembly further comprises at least one reflective element.

33. The device of claim 28 wherein the sheath assembly further comprises at least one irrigation channel.

34. The device of claim 28 wherein the sheath assembly further comprises at least one aspiration channel.

35. The device of claim 28 wherein the sheath assembly further comprises at least one channel for delivering a therapeutic agent therethrough.

36. The device of claim 28 wherein the sheath assembly further comprises an imaging system.

37. The device of claim 28 wherein the sheath assembly is adapted for use with an imaging system.

38. The device of claim 28 wherein the sheath assembly is a vascular catheter comprising at least one lumen.

39. The device of claim 22 wherein the coupling assembly is capable of connecting the probe to the sound conductor and a transducer capable of vibrating at an ultrasonic frequency.

40. The device of claim 22 wherein the sound conductor and the transducer are contained in a handle of the device.

41. The device of claim 22 wherein the coupling assembly comprises a releasable compressive clamp mounted externally to a collet residing in a housing assembly at the distal end of the coupling assembly, the collet capable of releasably engaging the ultrasonic probe.

42. The coupling assembly of claim 41 wherein the releasable compressive clamp is capable of exerting a compressive force on the collet causing the collet to engage the ultrasonic probe.

43. The device of claim 22 wherein the coupling assembly enables attachment and detachment of the ultrasonic probe.

44. The device of claim 22 wherein the sound conductor engaged to the coupling assembly is capable of controlling ultrasonic energy transferred to the ultrasonic probe.

45. The device of claim 22 wherein the horn is independent of a vibrational motion of the probe.

46. A method of delivering an ultrasonic energy to a region in need of a treatment inside of a body comprising:

decoupling a drive system from an ultrasonic probe by placing a discontinuity at a point where the drive system engages the ultrasonic probe wherein the drive system operates at a predictable frequency which is unaffected by changes in the frequency of the probe;

positioning the ultrasonic probe to the region in need of treatment inside of the body; and

delivering the ultrasonic energy to the region in need of treatment.

47. The method of claim 46 wherein decoupling occurs by providing a discontinuity at a point of attachment where the probe is attached to a horn such that the discontinuity creates an impedance mismatch between the probe and the horn.

48. The method of claim 46 wherein a diameter of the probe is approximately 0.025 inches or less.

49. The method of claim 46 wherein a diameter of the probe varies from the proximal end to the distal end.

50. The method of claim 46 wherein a handle is capable of delivering an amount of ultrasonic energy from the probe to the handle.

51. The method of claim 46 wherein the probe oscillates in a transverse mode.

52. The method of claim 46 further comprising engaging the drive system to the ultrasonic probe by a horn.

53. The method of claim 52 wherein the horn is a mason horn.

54. The method of claim 52 wherein a length of the horn is approximates an integer multiple of one-half wavelength of a vibration.

55. The method of claim 52 wherein the horn is a longitudinal drive system.

56. The method of claim 52 wherein the horn is a transverse drive system.

57. The method of claim 46 wherein the discontinuity is placed at an anti-node location along the probe.

58. The method of claim 46 wherein the discontinuity is placed at a node location along the probe.

59. The method of claim 54 wherein the length of the horn is increased by approximately one-fourth of a wavelength away from the discontinuity at the point of attachment of the drive system and the horn.

60. The method of claim 52 wherein the discontinuity is created by a significant change in diameter of the device at the point of attachment between the probe and the horn.

61. The method of claim 52 wherein the discontinuity is created by a change in the density of the device at the point of attachment between the probe and the horn.

62. The method of claim 52 wherein the horn is comprised of aluminum or an aluminum alloy.

63. The method of claim 52 wherein the horn is comprised of steel or a ferrous material.

64. The method of claim 46 wherein the probe is comprised of titanium or a titanium alloy.

65. The method of claim 52 wherein the discontinuity is created by using the horn comprised of a first material comprising a first elastic modulus and a probe comprised of a second material comprising a second elastic modulus wherein the the first elastic modulus and the second elastic modulus are different.

66. The method of claim 46 wherein the discontinuity results in a return of approximately 80 percent of the ultrasonic energy generated in the handle back into the horn and a transfer of the remaining approximately 20 percent of the ultrasonic energy into the probe.

67. The method of claim 46 wherein the drive system is independent of a vibrational motion of the probe.

68. A method of removing occlusions in a blood vessel using an ultrasonic device comprising the following steps:

(a) inserting an ultrasonic probe into the site of an occlusion in a body;

(b) positioning the ultrasonic probe in the proximity of the occlusion by an axial or rotational manipulation within the occluded blood vessel;

(c) mounting the ultrasonic probe to a coupling assembly;

(d) activating the transducer to cause oscillation of the ultrasonic probe in a substantially transverse mode with respect to a longitudinal axis of the probe;

(e) decoupling a drive system from the ultrasonic probe wherein the drive system operates at a predictable frequency which is unaffected by changes in the frequency of the probe; and

(f) providing ultrasonic energy to the ultrasonic probe to remove occlusions.

69. The method of claim 68 wherein the ultrasonic probe is a flexible, elongated guidewire.

70. The method of claim 68 wherein the ultrasonic probe further comprises a sheath assembly comprising at least one sheath.

71. The method of claim 70 wherein the sheath is capable of partially shielding a tissue from the ultrasonic probe at the site of the occlusion.

72. The method of claim 70 wherein the sheath assembly comprises an aspiration conduit, whereby fragments of an occlusive material are removed through the conduit.

73. The method of claim 72 wherein the sheath assembly further comprises an irrigation conduit wherein the irrigation conduit enables a supply of an irrigation fluid to the site of treatment in order to facilitate the removal of an occlusive material.

74. The method of claim 70 wherein the sheath assembly comprises a conduit for delivering a therapeutic agent through the conduit and to the treatment site.

75. The method according to claim 70 wherein the sheath assembly is a vascular catheter comprising at least one lumen.

76. The method of claim 68 wherein the drive system is independent of a vibrational motion of the probe.